510(k) K152166

JSM Insulin Pen Needle by Jeesung Medical Co., Ltd. — Product Code FMI

K152166 is an FDA 510(k) premarket notification submitted by Jeesung Medical Co., Ltd. for the device "JSM Insulin Pen Needle". The FDA issued a decision of Substantially Equivalent on July 11, 2016. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Jeesung Medical Co., Ltd. has at least 2 other 510(k) clearances on record.